Over-the-Counter Statins?

By: Grace von Oiste

Peer Reviewed

The Case for Statins

High intensity statin therapy routinely produces low-density lipoprotein cholesterol (LDL-C) reductions of 50% or more, an effect that is both dramatic and highly predictable. Few drug classes in cardiovascular medicine offer this degree of efficacy, and the data supporting their use are robust.

For every 39 mg/dL reduction in LDL-C, statins reduce major cardiovascular events by approximately 22% and all-cause mortality by 10%.¹ Furthermore, statins have been shown to reduce all-cause mortality (8% RRR), myocardial infarction (33% RRR), stroke (22% RRR), and composite cardiovascular outcomes (28% RRR).² Additionally, they have been shown to exert anti-inflammatory effects and, most importantly, to stabilize atherosclerotic plaques–benefits that are consistent across demographic groups and baseline cholesterol levels. LDL-C begins to fall within two weeks, with a maximal effect typically achieved by four weeks.³ Each doubling of a statin dose produces an additional six percentage point reduction in LDL-C.⁴

Taken together, this evidence positions statin therapy as one of the most well-validated pharmacologic interventions in preventive cardiology.

Who is Not Getting Them?

However, many eligible people are not currently on statin therapy. Under prior guidelines, over 70 million Americans were eligible for statin therapy, yet fewer than half were receiving it.⁵ The new 2026 ACC/AHA Dyslipidemia Guideline significantly expands eligibility criteria, meaning even more Americans now qualify for, but are not receiving, statin therapy.⁶

According to the National Health and Nutrition Examination Survey 2017-2020:⁵

• 93% of patients with LDL-C ? 190 mg/dL are not on a statin.
• 6% of patients with intermediate atherosclerotic cardiovascular disease (ASCVD) risk with risk enhancers are not on a statin.
• 4% with high ASCVD risk are not on a statin.
• 8% with diabetes are not on a statin.
• 5% with established ASCVD are not on a statin.

Statin therapy remains underprescribed among racial and ethnic minorities, women, uninsured individuals, and socioeconomically disadvantaged populations. Among eligible adults, statin use is highest in non-Hispanic Whites (58.3%) and lower in non-Hispanic Asian (49.2%), non-Hispanic Black (44.3%), and Hispanic (33.7%) adults. ² Higher income and insurance coverage are associated with statin use, while lack of health insurance is associated with reduced statin access, along with having multiple vulnerabilities (age ?65 years, being a woman, being Black, living in an area  with poverty level ?10%, or not having insurance).²

Side Effects

Muscle symptoms are the most reported side effect of statins. In randomized controlled trials, myalgias (with normal creatine kinase levels) occur in 1-5% of patients.⁷ In observational studies, this side effect is reported in 5-20%. However, the difference between statin and placebo groups is <1%, which suggests that the common muscle complaints might not be due to statins at all.⁸

The risk of new-onset diabetes with statin therapy is small, at only about 0.2% per year in the general population (hazard ratio 1.1 for moderate-intensity and 1.25 for high-intensity statins) and is largely limited to individuals who already have underlying diabetes risk factors such as obesity, impaired fasting glucose, metabolic syndrome, or elevated hemoglobin A1c.⁷

Clinically significant liver injury from statins is uncommon. Mild, usually asymptomatic transaminase elevations occur in about 1% of patients (annual excess risk ~0.08%), while severe hepatotoxicity is rare at approximately 0.001%.^8,9 A 2026 individual participant data meta-analysis published in the Lancet confirmed liver enzyme abnormalities as the most robust statin adverse effect and identified only two other genuine, but clinically minor, side effects: urinary composition alteration and edema, each with absolute annual excess risks below 0.1%.¹⁰

According to ACC guidelines and the 2026 meta-analysis, many frequently cited concerns, including renal dysfunction, cataracts, tendon rupture, hemorrhagic stroke in the general population, interstitial lung disease, low testosterone, cognitive impairment, depression, sleep disturbances, erectile dysfunction, peripheral neuropathy, and acute kidney injury, show no significant excess risk attributable to statins.¹⁰

The risk profile is real, but small. On the other hand, the cardiovascular risk reduction is large and measurable.

Should They be Available Over-the-Counter?

If statins work this well, are underused, and are safer than their reputation might suggest, should they be available over the counter (OTC)?

Earlier attempts at making statins available over the counter have failed. Using traditional drug-facts labels alone, correct self-selection ranged from 52–72%, and some studies have showed as little as 1% full comprehension of all eligibility criteria.¹¹ These concerns, particularly around drug-drug interactions and inadequate cholesterol monitoring, have prevented FDA approval of OTC statins.

However, newer technology-assisted self-selection models are changing the conversation. Two phase 3 trials have evaluated a web-based application for nonprescription rosuvastatin 5 mg access.¹¹ The initial study showed >95% concordance between consumer self-selection and independent clinician assessment for treatment eligibility.

A 10-year modeling study estimated that OTC statins would prevent

• 252,359 major coronary events
• 41,133 strokes
• 68,534 cardiovascular deaths

with predicted healthcare savings of $10.8 billion.¹²

Statins represent one of the most powerful preventive tools available in cardiovascular medicine. They are predictable, measurable, outcome-driven, and well-tolerated. The evidence suggests that statin underuse poses a greater population-level risk than statin-related toxicity.

A key concern with unsupervised OTC access is the potential to widen existing disparities and forgo the clinical encounter as an opportunity for patient education. At the same time, failing to improve access to such powerful drugs leaves millions of people untreated and at elevated cardiovascular risk.

OTC statins should move forward, with structured self-screening tools, pharmacist involvement, and clear frameworks to monitor their use. Additionally, patient education is central to implementation.

The evidence is clear: statins reliably prevent deaths when they reach the patients who need them most.

Grace von Oiste is a Class of 2027 medical student at NYU Grossman School of Medicine

Peer Reviewed by: Michael Tanner, MD, Executive Editor, Clinical Correlations.

Image of New Orleans Pharmacy Museum Courtesy of Jeremy Thompson, CC BY 2.0 <https://creativecommons.org/licenses/by/2.0>, via Wikimedia Commons

References

1. Michos ED, McEvoy JW, Blumenthal RS. Lipid Management for the Prevention of Atherosclerotic Cardiovascular Disease. N Engl J Med. 2019;381(16):1557-1567. doi:10.1056/NEJMra1806939
2. Chou R, Cantor A, Dana T, et al. Statin Use for the Primary Prevention of Cardiovascular Disease in Adults: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA. 2022;328(8):754-771. doi:10.1001/jama.2022.12138
3. Virani SS, Newby LK, Arnold SV, et al. 2023 AHA/ACC/ACCP/ASPC/NLA/PCNA Guideline for the Management of Patients With Chronic Coronary Disease: A Report of the American Heart Association/American College of Cardiology Joint Committee on Clinical Practice Guidelines. Circulation. 2023;148(9):e9-e119. doi:10.1161/cir.0000000000001168
4. Collins R, Reith C, Emberson J, et al. Interpretation of the evidence for the efficacy and safety of statin therapy. Lancet. 2016;388(10059):2532-2561. doi:10.1016/s0140-6736(16)31357-5
5. Chobufo MD, Regner SR, Zeb I, Lacoste JL, Virani SS, Balla S. Burden and predictors of statin use in primary and secondary prevention of atherosclerotic vascular disease in the US: from the National Health and Nutrition Examination Survey 2017-2020. Eur J Prev Cardiol. 2022;29(14):1830-1838. doi:10.1093/eurjpc/zwac103
6. Writing Committee Members; Blumenthal RS, Morris PB, Gaudino M, et al. 2026 ACC/AHA/ AACVPR/ABC/ACPM/ ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Dyslipidemia: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2026;153(17):e1154-e1276. doi:10.1161/CIR.0000000000001423. Epub 2026 Mar 13.
7. Grundy SM, Stone NJ, Bailey AL, et al. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2019;73(24):e285-e350.\. doi:10.1016/j.jacc.2018.11.002. Epub 2018 Nov 10.
8. Newman CB, Preiss D, Tobert JA, et al. Statin Safety and Associated Adverse Events: A Scientific Statement From the American Heart Association. Arterioscler Thromb Vasc Biol. 2019;39(2):e38-e81. doi:10.1161/atv.0000000000000073
9. Cai T, Abel L, Langford O, et al. Associations between statins and adverse events in primary prevention of cardiovascular disease: systematic review with pairwise, network, and dose-response meta-analyses. BMJ. 2021;374:n1537. doi:10.1136/bmj.n1537
10. Cholesterol Treatment Trialists’ Collaboration. Assessment of adverse effects attributed to statin therapy in product labels: a meta-analysis of double-blind randomised controlled trials. Lancet. 2026;407(10529):689-703. doi:10.1016/s0140-6736(25)01578-8
11. Nissen SE, Hutchinson HG, Wang TY, et al. Technology-Assisted Self-Selection of Candidates for Nonprescription Statin Therapy. J Am Coll Cardiol. 2021;78(11):1114-1123. doi:10.1016/j.jacc.2021.06.048
12. 12. Stomberg C, Albaugh M, Shiffman S, Sood N. A cost-effectiveness analysis of over-the-counter statins. Am J Manag Care. 2016;22(5):e294-303.

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